MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-03-22 for SPYSCOPE DS M00546600 4660 manufactured by Boston Scientific Corporation.
[139606712]
The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown. (b)(4). A visual assessment was performed. Only the detached working channel sleeve (wcs) was returned, and appears stretched. The reported complaint of device entrapment of device or device component was confirmed, and specifically analyzed as spyscope detached/separated to address the detached working channel sleeve. It is possible that operational factors, such as user technique/handling, patient anatomy, and accessory use, contributed to the reported complaint, however it is unknown what caused the wcs component to detach from the spyscope ds device. Based on all gathered information, the complaint investigation conclusion code selected is cause not established, which indicates that the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event. A manufacturing batch record review was unable to be performed as the lot number is unknown. However, a ship history review was performed to identify the most probable lots, and a dhr (device history record) review on the most probable lots did not identify any deviations in the manufacturing processes that could have contributed to the event.
Patient Sequence No: 1, Text Type: N, H10
[139606713]
It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019. According to the complainant, during the procedure, an ehl probe was stuck in the spyscope ds. When they tried to remove it, a piece of the ehl probe broke off and they were able to remove the piece with forceps. The procedure was completed using another ehl probe. There were no patient complications reported as a result of this event. This event has been deemed reportable based on the investigation finding: detached working channel sleeve.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-01436 |
| MDR Report Key | 8445256 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-22 |
| Date of Report | 2019-03-22 |
| Date of Event | 2019-01-24 |
| Date Mfgr Received | 2019-03-01 |
| Date Added to Maude | 2019-03-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 780 BROOKSIDE DRIVE |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPYSCOPE DS |
| Generic Name | CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID |
| Product Code | FBN |
| Date Received | 2019-03-22 |
| Returned To Mfg | 2019-02-06 |
| Model Number | M00546600 |
| Catalog Number | 4660 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-22 |